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Regulatory requirements for medicinal products for human use in the context of the COVID-19 pandemic

  • 2 November 2021
  • active substance, API, certificate, change, coronavirus, COVID-19, ECMP, EudraVigilance, expectations, flexibility, GDP, GMP, ICSR, import, IMs, inspection, MAH, manufacturing, pandemic, pharmacovigilance, PV, QP, QP certification, QPPV, regulation, regulatory, remote, SARS-Cov-2, SMs, variation,
The European Commission, EMA and the European medicines regulatory network have developed a question-and-answer (Q&A) document to provide guidance to stakeholders on adaptations to the regulatory framework to address challenges arising from the COVID-19 pandemic, with a particular focus on crucial medicines for use in COVID-19 patients. The document explains some regulatory flexibilities that can
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The use of monoclonal antibodies to treat COVID-19

  • 8 February 2021
  • ACTEMRA, application, AstraZeneca, AZD7442, bamlanivimab, benefits, casirivimab, Celltrion, CHMP, cilgavimab, CMA, conditional marketing authorisation, COVID-19, CT-P59, EC, EEA, Eli Lilly, EMA, etesevimab, EU, Evusheld, F. Hoffman-La Roche Ltd, FDA, GlaxoSmithKline, GSK4182136, imdevimab, mAb, monoclonal antibodies, regdanvimab, Regeneron Pharmaceuticals Inc., Regkirona, REGN-COV2, risks, RoActemra, Roche, rolling review, SARS-Cov-2, sotrovimab, tixagevimab, tocilizumab, Vir Biotechnology Inc., VIR-7831,
EMA’s human medicines committee (CHMP) is reviewing available data on the use of the monoclonal antibodies casirivimab, imdevimab, bamlanivimab and etesevimab to treat patients with COVID-19 who do not require oxygen supplementation and who are at high risk of progressing to severe COVID-19. The committee will carry out two separate reviews, one for the casirivimab/imdevimab
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Vaccines against COVID-19

  • 10 December 2020
  • application, AstraZeneca, benefits, BioNTech, BNT162b2, ChAdOx1-SARS-CoV-2, CHMP, CMA, conditional marketing authorisation, COVID-19, COVID-19 Janssen, COVID-19 Vaccine (inactivated adjuvanted), COVID-19 Vaccine Janssen, CVST, DIC, EC, EEA, EMA, EU, FDA, Gam-COVID-Vac, Gamaleya National Centre of Epidemiology and Microbiology, Janssen-Cilag International N.V., Jcovden, MHRA, Moderna Biotech Spain S.L., mRNA, mRNA-1273, Novavax CZ a.s., Nuvaxovid, Oxford University, Pfizer, R-Pharm Germany GmbH, risks, rolling review, Russia, Sanofi Pasteur, SARS-Cov-2, Spikevax, Sputnik V, vaccine, Valneva, Vaxzevria, VidPrevtyn Beta,
Comirnaty (BNT162b2) (BioNTech and Pfizer) Spikevax (mRNA-1273) (Moderna Biotech Spain, S.L.) Vaxzevria (AstraZeneca/Oxford University) Jcovden (COVID-19 Vaccine Janssen) (Janssen-Cilag International N.V.) Nuvaxovid (Novavax CZ, a.s.) COVID-19 Vaccine (inactivated, adjuvanted) (Valneva) VidPrevtyn Beta (Sanofi Pasteur) Sputnik V (Gam-COVID-Vac) (Gamaleya National Centre of Epidemiology and Microbiology, Russia)     EXTENSION OF INDICATION Update [25/11/2021] EMA’s human medicines
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